TaiMed Med Biolo logics, gics, Inc. c. Septemb ember er 2018 - PowerPoint PPT Presentation

TaiMed Med Biolo logics, gics, Inc. c. Septemb ember er 2018 1

Corporate Structure  TaiMed Biologics, Inc. in Taipei, Taiwan • Corporate Headquarter/Administration • Finance/Accounting • Research & Development （ GMP Analytical Lab ）  TaiMed Biologics, HsinChu Branch, Taiwan • Manufacturing Operations • QA/QC • Supply Chain Management  TaiMed Biologics USA in Irvine, CA, USA • Clinical • Regulatory • Business Development 中裕新藥 2

Financial Status  TaiMed has been a publicly traded company on the Taipei Exchange Emerging Stock Market (stock code: 4147) since 2010.  IPO on Nov 23, 2015 and traded on the Taipei Exchange Market (OTC)  Current market cap is approximately USD$2 Billion MSCI standard index from May, 2016  Ruentex hold ~17% of TaiMed National Development Fund hold ~16% of TaiMed  Shareholders exceed 24,000 (April, 2018). 中裕新藥 3

Fundraising History  Raised a total of USD$208M through four fundrasing rounds : • First round (2007-2008) USD$30M • Second round (2010) USD$22M • Third round (2014) USD$46M • Forth round for IPO (2015) USD$110M  Cash in hand as of 6/30/2018 : USD$85M  Total shares outstanding : 250M 中裕新藥 4

TROGARZO (ibalizumab) – Now Available (in US)! • Humanized monoclonal antibody being developed for the treatment of multidrug resistant (MDR) HIV-1 infection • Binds primarily to the second extracellular domain of CD4+ T cell receptor, away from MHC II molecule binding sites ibalizumab gp120 D1 D2 CCR5 / CXCR4 CD4 • Prevents HIV from infecting CD4+ T cells while preserving normal immunological function 中裕新藥

Milestones Ibalizumab (TMB-355) • US Market Launch – 4/30/2018 • The FDA granted approval of Trogarzo (trade name for ibalizumab) to TaiMed Biologics - 3/6/2018 (US time) • First HIV treatment approved with a new mechanism of action in more than 10 years • First monoclonal antibody for MDR HIV-1 • Only ARV that does not require daily dosing (infused q2w) • Completed Phase III trial – 11/2016 (US, TW) • Granted US FDA breakthrough designation therapy for MDR patients in IV dosage form – 2/2015 • Granted US FDA orphan drug designation for MDR patients – 10/2014

The phase III clinical trial used to obtain FDA approval for Trogarzo ™ (ibalizumab-uiyk) injection in the United States were published in the most recent edition of The New England Journal of Medicine 中裕新藥

TaiMed Is Committed to HIV Drug Development with a Solid Pipeline TMB-607 • Protease inhibitor • Phase I clinical trial underway (IND sponsored by Temple University) TMB-365 • Ibalizumab-based, IgG1-scaffold, also blocks domain 2 • FcRn, LM52 glycan modifications • Broader, wider viral coverage range and higher, greater anti-infectivity against HIV • PK/GLP Tox study underway TMB – Bispecific • Bispecific neutralizing antibody targets two different antigens • One targets CD4 like ibalizumab while the other targets gp120 • Currently in preclinical development TMB – ADC • Antibody-drug conjugate • Tripartite drugs comprising a target-specific mAb conjugated to a potent HDAC inhibitor via a stable linker • Currently in discovery 中裕新藥 8

2018 2H Target for Operations Prepare the Trogarzo submission for EMA regulatory • approval in Europe Review will be under the accelerated assessment procedure  Initiation of paediatric investigation plan deferred  Phase III start of Trogarzo IV push proposal in US • Pre IND meeting with FDA for TMB-365 in US • Phase I start of Bi-specific in US at the end of Q4 • Continuing phase 1 of TMB-607 in US • 中裕新藥

Trogarzo US Addressable Market* US HIV infected US MDR HIV population population 1.4 million 20 – 25 K US HIV treated population 450 – 650 K population requiring new treatment 10 – 12 K *EU patient population is of similar size 中裕新藥 10

Research for Market Trend  Our sales and marketing partner - Theratechnologies  Thera expects to complete the private and public insurance coverage in 2018  In-line with expectations for the product launch  Trogarzo should mimic the uptake of other successful HIV product launches Years post-launch 中裕新藥 TaiMed Biologics Confidential & Proprietary 11

Theratechnologies Partnership North American Agreement European Agreement Date of agreement March 18, 2016 March 6, 2017 12 years from approval (country-by- Term 12 years from FDA approval country basis) 52% (57% of annual sales exceeding Transfer Price 52% of Net Sales US$50M in European Territory Payment at signature US$1M (cash) US$3M (common shares) US$5M (cash – payable one year after US$4M (common shares) Upfront and launch launch) US$5.5M (cash – payable through an milestone US$5M (cash – payable once EU sales increase in transfer price) reach US$50M) Development US$3M (Intramuscular administration 50% of European clinical trial costs (if milestones approval) any) Up to US$207M upon reaching various Up to US$80M upon reaching various Commercial milestones sales levels (up to US$1B) and label sales levels (up to US$1B) expansion objectives 中裕新藥 12

Accounting Treatment for Theratechnologies contract IFRS 15 “ Revenue from Contracts IAS 18 “ Revenue ” with Customers” Effective Date From January 1, 2018 Before December 31, 2107 52% of Net Sales at the completion 52% of Net Sales at the completion Transfer Price time of sales time of sales Thera shares are measured at fair Thera shares are measured at fair market value. The changes in the Valuation on shares market value. The changes in the carrying amount of shares are received carrying amount of shares are recognized in other comprehensive recognized in non-operating income income Recording as liability- “performance Cash and shares The upfront payments and obligation” at the time of upfront upfront and launch development milestone payments are milestone （ including received or milestone achieved . recognized according to the degree of US$5.5M milestone ） Recognizing revenue based on performance over the estimated expected sales volume-based performance period stipulated in the method at the drug launch time or Development agreement on a straight-line basis; development milestone achieved. milestones Evaluate, on an on-going basis, each milestone in the contract to the commercial milestone payments Commercial determine whether including an are recognized as revenue when the milestones estimate of variable consideration in commercial milestones are achieved the transaction price at the drug and the revenue is not expected to be launch time, using the most likely reversed. amount method. Adjustment for Estimate adjustment if significant straight-line based amortization except amrotization change in expected sales volume. for amendment of contract periods. 13 Note: the above accounting treatment is only suitable for TaiMed. 中裕新藥

Taimed Biologics Zhubei (Manufacturing Operations) 中裕新藥 14

Taimed Biologics Zhubei  cGMP Biologics Manufacturing Facility • Process Development and Manufacturing • QC Release and Quality Assurance • Global Supply Chain Management 3 rd Party Contract Manufacturer Management • 中裕新藥 15

Facility Location 中裕新藥 16

Facility Overview  State-of-the-Art Five Story Building with ~ 5500 m 2 （ Production Area is 1142 m 2 )  1F: Warehouse  2F:  QC and Microbiology Labs – Routine release and stability testing, environmental monitoring  Process development Lab – Process development & characterization, scale-up and optimization  3F: Biologics production area  4F: Cold chain storage of intermediates, drug substance and finished goods 中裕新藥 17

Facility Design Principles  Maintain equipment “sameness” between Zhubei facility and Wuxi Biologics to ensure high level of product comparability  Use of single-use technology to maximize manufacturing efficiency and minimize product contamination risks  One 500L and four 2000L single-use bioreactors (SUB) to maintain manufacturing flexibility to produce both commercial and clinical batches  Full production capacity is 48 batches @ 4000L scale 中裕新藥 18

Biologics Manufacturing Process Source: Trends in Biotechnology, Volume 31, Issue 3, p147 – 154, March 2013 19 中裕新藥

Firms and Vendors  cGMP Facility Design:  Facility design with Nova Pharma Solutions (Malaysia) and BPTC (USA)  Facility Construction:  Ruentex Engineering & Const.Co ( 潤弘精密公司 ) – Building design and construction  China Ecotek ( 中宇環保 ) – Facility & utility engineering, cleanroom  Production Equipment:  Alfa Laval, Merck, Sartorius, ThermoFisher, etc. 中裕新藥 20

Timeline  Ground-breaking ceremony – June 2017  Topping-out ceremony – Nov 2017  Obtained building use license – Feb 2018  Initiated facility utility engineering and interior construction project – Mar 2018  Target facility completion – Sept 2018 Total Investment NT$1B 9/2017 10/2017 4/2018 21 中裕新藥

Timeline 12 Months Stability PD/Tech 3 PPQ Equipment Data Transfer Commercial Batches IOQ from Wuxi Production FDA 3Q2018 – 1Q2019 2H/2019 Inspection 3Q2018 – 2Q2019 3Q2019-4Q2020 中裕新藥 22